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Therapy Optimization in Multiple Sclerosis (MS) (TOP MS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:
NCT00819000
First received: January 7, 2009
Last updated: January 28, 2013
Last verified: January 2013

January 7, 2009
January 28, 2013
December 2008
December 2012   (final data collection date for primary outcome measure)
Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819000 on ClinicalTrials.gov Archive Site
Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Therapy Optimization in Multiple Sclerosis (MS)
TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies

The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies

Multiple Sclerosis
Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b
MS therapies (listed above) used according to prescribers' instructions.
Other Names:
  • Copaxone®
  • Avonex®
  • Rebif®
  • Betaseron®
Treated MS Subjects
Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies
Intervention: Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b
Coyle PK, Cohen BA, Leist T, Markowitz C, Oleen-Burkey M, Schwartz M, Tullman MJ, Zwibel H. Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes. BMC Neurol. 2014 Mar 13;14:49. doi: 10.1186/1471-2377-14-49.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2878
January 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, 18 years of age or older, with a diagnosis of MS.
  • Being treated with Glatiramer Acetate (GA) or (IFN)-β
  • Receiving therapy from a participating Specialty Pharmacy

Exclusion Criteria:

  • Has any contraindication to GA or IFN-β therapy, including pregnancy, trying to become pregnant, or breast feeding during the study
  • Has received an experimental drug in the last thirty (30) days other than Fampridine SR (4-aminopyridine or 4-AP)
  • Unlikely to be able to participate for the full two years of the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00819000
PM032
No
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
Teva Neuroscience, Inc.
Not Provided
Study Chair: MerriKay Oleen-Burkey, PhD Teva Neuroscience, Inc.
Study Director: Howard Zwibel, MD Neurologic Center of South Florida
Teva Pharmaceutical Industries
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP